FML^® Liquifilm^® Ophthalmic 1 mg/ml eye drops, suspension

One millilitre contains 1 mg Fluorometholone

For a full list of excipients, see section 6.1.

Eye drops, suspension.

A white, microfine suspension.

For corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Topically as drops into the conjunctival sac.

1 – 2 drops into the conjunctival sac 2 – 4 times daily. During the first 24 to 48 hours of treatment, the dosage may be safely increased to 2 drops at one hour intervals. The treatment should not be withdrawn too early.

The safety and efficacy of FML has not been proven in children aged 2 years or less.

Hypersensitivity to the active substance or to any of the excipients.

Ocular viral infections, among others keratitis dendritica and varicella-zoster infections.

Ocular bacterial infection, among others tuberculosis.

Ocular fungal infections.

Eye drops containing corticosteroids should not be used for longer than a week except under an eye specialist's careful surveillance combined with regular measurement of intraocular pressure.

Prolonged use may result in glaucoma, corneal thinning and perforation, subcapsular cataract formation, or may facilitate the development of secondary ocular infections especially from fungi and viruses.

A 'red eye', where the diagnosis is unconfirmed, may be due to herpes simplex virus, and a corticosteroid may aggravate the condition, leading to corneal ulceration, with possible damage to vision and even loss of the eye.

Adverse topical effects of steroid treatment, such as skin atrophy, striae and teleangiectasia, may occur especially in the facial skin.

FML contains benzalkonium chloride which is irritant to the eye and could cause discoloration of soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before FML is used and wait for at least 15 minutes before reinsertion.

Concomitant ocular medication should be administered 5 minutes prior to the installation of FML.

None known.

Pregnancy

Fluorometholone should only be used during pregnancy if it is clearly necessary. Fluorometholone is, as are other corticosteroids, teratogenic in animal studies.

Lactation

Fluorometholone may pass into breast milk so it is recommended that FML is not used in nursing mothers unless clearly necessary.

Instillation of any eye drop could result in transient blurring of vision. If this occurs, the patient should wait for the blurring to subside before driving or operating machinery.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The following undesirable effects have been reported since FML was marketed.

Frequency:

Common: affecting >1/100 and <1/10 patients

Not known: the incidence cannot be determined from available information.

Eye disorders

Not known: Eye irritation, conjunctival hyperaemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid oedema, blurred vision, eye discharge, eye pruritis, lacrimation increased, ocular hyperaemia, eye oedema, mydriasis, eye inflammation, corneal disorder, cataract (including subcapsular).

Immune system disorders

Not known: Hypersensitivity

Investigations

Common: Intraocular pressure increased

Nervous system disorders

Not known: Dysgeusia, headache, dizziness

Skin and subcutaneous tissue disorders

Not known: Rash

Vascular disorders

Not known: Hypertension

No case of overdose has been reported. Overdosage will not ordinarily cause acute problems.

If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline. If accidentally ingested, the patient should drink fluids to dilute.

Pharmacotherapeutic group: Corticosteroids, plain

ATC code: S01BA07

Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation.

Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection mediators thus damping inflammatory reactions (swelling, fibrin deposition, capillary dilatation, phagocyte migration) and also capillary proliferation, collagen deposition and scarring.

Although topical corticosteroid treatment often increases intraocular pressure both in normal eyes and in the eyes of a patient with increased intraocular pressure, fluorometholone increases intraocular pressure less than, for example, dexamethasone. A study showed that fluorometholone after six weeks' treatment increased intraocular pressure statistically significantly less than dexamethasone (mean change dexamethasone: 9 mmHg, mean change fluorometholone: 3 mmHg).

When tritium-labelled 0.1 % fluorometholone suspension was administered locally, the peak concentration of the radioactive substance in aqueous humour was achieved 30 minutes after administration. A rapidly forming metabolite occurred at high concentrations both in aqueous humour and corneal extracts, which shows that fluorometholone is metabolised to a certain extent while penetrating the cornea and aqueous humour.

Any preclinical safety data relevant to the prescriber has been included in other sections of the Summary of Product Characteristics.

Polyvinyl alcohol

Benzalkonium chloride

Edetate disodium

Sodium chloride

Disodium phosphate, heptahydrate

Sodium dihydrogen phosphate, monohydrate

Polysorbate 80

Sodium hydroxide (for pH adjustment)

Purified water

None known.

36 months unopened.

Discard 28 days after first opening.

Do not store above 25°C. Do not freeze.

A bottle and an applicator tip of low density polyethylene (LDPE). A screw cap of polystyrene (MIPS).

The bottle contains 5 ml or 10 ml of suspension.

Not all pack sizes may be marketed.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface.

The use of the product by more than one person may spread infection.

Keep the bottle tightly closed when not in use.

There are no special precautions for disposal.

Allergan Limited

Marlow International

The Parkway

Marlow

Bucks

SL7 1YL

UK

PL 00426/0028

15^th July 2003

May 2011